Adjustable Rod Assembly

ABSTRACT

An adjustable rod for spinal corrective surgery is provided that includes a first elongate member and a second elongate member, each having rod portions couplable to one or more bone connecting elements and expansion portions slidably moveable with respect to one another. A plurality of holes in each expansion portion are alignable with one another to choose the length of the adjustable rod and a locking element is inserted through a pair of aligned holes to couple the first and second elongate members and secure or fix the length of the expandable rod.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/607,413 filed Jan. 28, 2015, which is a continuation of U.S. patentapplication Ser. No. 12/610,888 filed Nov. 2, 2009, now U.S. Pat. No.8,974,500 issued Mar. 10, 2015, which claims the benefit of U.S.Provisional Patent Application No. 61/110,711 filed on Nov. 3, 2008,each of which are herein incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

It is desirable to provide an elongate spinal fixation rod for use inspinal deformity correction that is adjustable in size to allowadjustments to be made intraoperatively, as well as postoperatively toaccommodate the spine as it grows or as the deformity is corrected.

It is further desirable to facilitate percutaneous insertion of anadjustable rod to reduce the invasiveness of the surgery as well as toreduce the occurrence of postoperative infection. Accordingly, anadjustable rod assembly that is configured for percutaneous implantationis desirable.

BRIEF SUMMARY OF THE INVENTION

The present invention relates generally to orthopedics. Morespecifically, a preferred embodiment of the present invention relates toan adjustable elongated assembly for deformity correction. Theadjustable elongated assembly, also interchangeably referred to as anadjustable rod assembly, is preferably used for correcting orstraightening a human spine.

The adjustable rod assembly preferably includes at least one boneconnecting element, a first elongate member, a second elongate memberand a locking element. The bone connecting element preferably is forattaching to the rib cage, pelvis or spine of a patient, including thevertebrae of a patient. The first elongate member preferably includes afirst rod portion configured for coupling to one of the bone connectingelements and a first expansion portion, the first expansion portionfurther including a plurality of bore holes, preferably blind boreholes, in an outer surface. The second elongate member preferablyincludes a second rod portion configured for coupling to one of the boneconnecting elements and a second expansion portion slidably moveablewith respect to the first expansion portion. The second expansionportion preferably further includes a plurality of through holes in anouter surface. The locking element preferably includes a pin configuredto be insertable into at least one of each of the bore holes and thethrough holes to thereby couple the first and second elongate memberstogether and fix or secure the length of the adjustable rod assembly.The bone connecting element preferably is rotationally adjustable aboutat least one of the first rod portion and the second rod portion. Thefirst elongate member may be straight or have a lordotic or kyphoticcurvature. Likewise, the second elongate member may be straight, or havea lordotic or kyphotic curvature. Alternatively, portions of the firstand second elongate members may be straight while other portions arecurved.

The first and second elongate members, or portions thereof, preferablyare curved such that their outer surface defines the direction of theradius of curvature so as to form a lordotic curvature. The elongatemembers or portions thereof may also be relatively straight or form akyphotic curvature. The first expansion and second expansion portionspreferably are each curved and each preferably has the same radii ofcurvature. The radius of curvature of the first and second elongatemembers and/or the first and second expansion portions preferably isbetween about 200 mm to about 520 mm. The bone connecting elements maytake on many forms and configurations, and may include, for example;hooks, including, for example, spinal hooks, lamina hooks, pediclehooks, transverse processes hooks, spinal processes hooks, pelvic hooks,and S-hook members; clamp assemblies; screws, including, for example,pedicle screws, and pelvic screws. The clamp assembly may take manyforms and configurations, such as, for example, a rib hook and a ribhook cap, a “C” clamp or other clamp configurations.

The adjustable rod assembly may form a system comprising a plurality offirst elongate members of different sizes and shapes and a plurality ofsecond elongate members of different sizes and shapes. The adjustablerod assembly system may further comprise multiple bone connectingelements including at least one clamp for attachment to a patient's rib,at least one hook for attachment to a patient's vertebra, preferably thelamina of the vertebra, and/or at least one hook for attachment to apatient's pelvis area.

A method of implanting an adjustable rod assembly for correcting orstraightening a human spine is also disclosed. The method may includethe steps of inserting a first bone connecting element through a firstopening to a first location in a patient, coupling the first boneconnecting element to bone at the first location, inserting a secondbone connecting element through a second opening to a second location ina patient, coupling the second bone connecting element to bone at thesecond location, inserting a first elongate member through the firstopening, coupling the first elongate member to the first bone connectingelement, inserting a second elongate member through the second opening,coupling the second elongate member to the second bone connectingelement; and coupling the elongate members together.

The method may further comprise the steps of creating a third opening ata third location and inserting a coupler or locking element through thethird opening to couple the elongate members together. The firstelongate member may have a first rod portion and the method may furthercomprise the steps of coupling the first bone connecting element to thefirst rod portion, and angularly adjusting the first bone connectingelement relative to the first rod portion. The method may furthercomprise the step of fixing the angular orientation of the first boneconnecting element with respect to the first rod portion.

Other arrangements, structures, features, embodiments, aspects,instrumentalities, methods and constructions of the adjustable rodassembly will be evident to those skilled in the art upon review of thedetailed description, and the present invention should not be limited tothe summary, and/or preferred embodiments shown and described.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the application, will be better understood whenread in conjunction with the appended drawings. For the purposes ofillustrating the adjustable rod assembly of the present application,drawings of preferred embodiments are shown. It should be understood,however, that the application is not limited to the precisearrangements, structures, features, embodiments, aspects, methods andinstrumentalities shown, and the arrangements; structures, features,embodiments, aspects, methods and instrumentalities shown may be usedsingularly or in combination with other arrangements, structures,features, embodiments, aspects, methods and instrumentalities. In thedrawings:

FIG. 1 illustrates an exploded perspective view of an adjustable rodassembly in accordance with a first preferred embodiment of the presentinvention;

FIG. 2 illustrates an exploded perspective view of an adjustable rodassembly in accordance with a second preferred embodiment of the presentinvention;

FIG. 3 illustrates a top view of the adjustable rod assembly of FIG. 2connected to the rib cage and pelvis of a patient;

FIG. 4 illustrates an exploded side view of an adjustable rod assemblyin accordance with a third preferred embodiment of the presentinvention;

FIG. 5 illustrates a perspective view of the adjustable rod assembly ofFIG. 4;

FIG. 6. illustrates an exploded perspective view of a first embodimentof the connecting assembly of the adjustable rod assembly;

FIG. 7 illustrates a bottom view of the assembled connecting assembly ofFIG. 6;

FIG. 8 illustrates a cross-sectional view of the assembled connectingassembly of FIG. 7 along line 8-8;

FIG. 9 illustrates a perspective view of the connecting assembly of theadjustable rod assembly of FIG. 6;

FIG. 10 illustrates a side elevational view of a locking element for usein the adjustable rod assembly;

FIG. 11 illustrates a perspective view of a lamina hook of theadjustable rod assembly of FIG. 1;

FIG. 12 illustrates a perspective side view of a rib hook of the boneclamping assembly of FIGS. 1-5;

FIG. 12A illustrates a cross-sectional view of the rib hook of FIG. 12along line 12A-12A;

FIG. 12B illustrates a perspective back view of the rib hook of FIG. 12;

FIG. 13 illustrates a perspective view of the rib hook cap of the boneclamping assembly of FIGS. 1-4;

FIG. 14 illustrates a perspective view of a parallel connector of theadjustable rod assembly of FIG. 2;

FIG. 15 illustrates a perspective view of a portion of an adjustable rodassembly in accordance with a fourth preferred embodiment of the presentinvention;

FIG. 16 illustrates a side perspective view of the transverse connectorof the adjustable rod assembly of FIG. 14;

FIG. 17 illustrates a perspective side view of the transverse rib hookof the adjustable rod assembly of FIG. 15;

FIG. 17A illustrates a cross-sectional view of the transverse rib hookof FIG. 17 along line 17A-17A; and

FIG. 17B illustrates a perspective back view of the transverse rib hookof FIG. 12.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower”, “upper”,“top” and “bottom” designate directions in the drawings to whichreference is made. The words “inner”, “inwardly” or “distally” and“outer”, “outwardly” or “proximally” refer to directions toward and awayfrom, respectively, the geometric center of the adjustable rod assemblyand related parts thereof, or the patient. The words, “anterior”,“posterior”, “superior,” “inferior”, “lateral” and “medial” and relatedwords and/or phrases designate preferred positions and orientations inthe human body to which reference is made and are not meant to belimiting. The terminology includes the above-listed words, derivativesthereof and words of similar import.

In reference to FIGS. 1-5, and 15, an adjustable rod assembly 10 isprovided that includes one or more adjusting assemblies 15 and one ormore bone connecting elements 50. U.S. Pat. No. 5,092,889 and U.S. Pat.No. 5,261,908 describe, show and disclose adjustable rod assembliessimilar to those described herein which are for use to correct andalleviate similar conditions, the contents of U.S. Pat. Nos. 5,092,889and 5,261,908 are incorporated in their entirety herein by reference.

The adjusting assemblies 15 in FIGS. 1-9 and 15 may include a firstelongate member or distal extension 20, a second elongate member orproximal extension 30, and a locking element 40. The first and secondelongate members 20, 30 and the locking element 40 can be formed from anumber of biocompatible materials, such as, for example, titanium,stainless steel, titanium alloy, cobalt-chrome, composites, ceramics,PEEK, or other polymers. These materials are not limiting and theelongate members 20, 30 and the locking element 40 may be constructed ofnearly any biocompatible material that is able to take on the desiredshape and withstand the normal operating conditions (e.g., theenvironmental and physical property requirements) of the adjustingassemblies 15.

Referring to FIGS. 6-9, the first elongate member 20 of the adjustingassembly 15 includes a male expansion portion 24 and a first rod portion22 configured for coupling to one or more first bone connecting elements50. The male expansion portion 24 preferably includes an outer surface25, an inner surface 26, and a pair of side surfaces 27, 28 that combineto form a T-bar shape when the male expansion portion 24 is viewed incross-section. Disposed through the outer surface 25 of the maleexpansion portion 24 is a plurality of blind bore holes 21, as is bestshown in FIG. 6. Preferably the blind bores 21 do not extend all the waythrough the male expansion portion 24 from the outer surface 25 to theinner surface 26.

The second elongate member 30 includes a female expansion portion 34 anda second rod portion 32 configured for coupling to one or more secondbone connecting elements 50. The female expansion portion 34 isconfigured to slidably translate with respect to the male expansionportion 24. The female expansion portion 34 preferably includes an outersurface 35, a pair of side surfaces 37, 38 and an inner surface 36 withan opening 39 that preferably form a sleeve like member with a “C” shapewhen the female expansion portion 34 is viewed in cross-section. Thesleeve like expansion portion 34 has a channel to receive the maleexpansion portion 24. Disposed through the outer surface 35 of thefemale expansion portion 34 is a plurality of complementary throughholes 31.

While the surfaces of male extension portion 24 and the female extensionportion 34 have been shown and described as forming a T-Bar shape and aC-shaped channel, other shapes and geometries may be utilized for themale extension portion 24, such as, for example, an I-beam shape, andfor the female extension portion 34, such as, for example, an I-shapedor T-shaped channel. The first elongate member 20 preferably translatesor slides relative to the second elongate member 30, preferably whilelimiting or preventing rotation of elongate members 20, 30 with respectto each other. The shape and interaction between the two members 20, 30preferably prevents or resists relative rotation between the twomembers. Preferably the male expansion portion 24 slides and telescopeswithin the female expansion portion 34, however, it is contemplated thatthe elongate members can slide and telescope in a side by side manner aswell. The sliding action between first elongate member 20 and the secondelongate member 30 permits the surgeon to adjust the length of theadjustable rod assembly 10 before or during the procedure.

Referring to FIG. 10, the locking element or coupler 40 preferablyincludes a substantially flat outer surface 42, and a pair of sidesurfaces 47, 48, and is shaped as a C-clamp having a prong 41 protrudingfrom its inner surface 43 in the same direction as the side surfaces 47,48. The prong 41 is configured to be insertable in the through holes 31and the blind bore holes 21 to prevent relative motion between first andsecond elongated members 20, 30. The bottom inside surface 44 of thelocking element 40 has a small projection 45 forming a shoulder 46 forengaging and snapping onto a ledge 33 formed in the side surfaces 37, 38of the female extension 24. The locking element 40 is preferablyelastically deflectable so that the side walls 37, 38 can deflect andexpand so that projections 45 can extend down over ledge 33. In thismanner, the locking element 40 is snap fitted and attached to theelongate member 30 as the projections 45 engage and couple to the ledge33. The sliding action between the elongate members 20, 30 permits thesurgeon to adjust the length of the adjustable rod assembly 10 while thelocking element 40 allows a surgeon to secure or fix the length of theadjustable rod assembly at its desired length.

The elongate members 20, 30 in the adjustable rod assembly 10 of FIG. 1are substantially straight while the elongate members 20, 30 of theadjustable rod assembly 10 of FIGS. 2-5 and 15 are slightly curved,having a kyphotic curvature when attached to bone. In this regard, theends of the curved elongate members in the embodiments of FIGS. 2-5 and15 are bent inward toward the inner surfaces 26, 36 of the elongatemembers 20, 30. When the adjustable rod assembly is attached to theposterior side of the patient as shown in FIG. 3 the radius of curvatureof the elongated member is toward the inner surfaces 26, 36 of theelongated members forming and defining a kyphotic curvature. In theadjusting assemblies 15 of FIGS. 6-9 the radius of curvature of theelongated members is toward the outer surfaces 25, 35 of the elongatemembers forming and defining a lordotic curvature when the adjustablerod assembly 10 is attached to a patient. The ends of the curvedelongate members 20, 30 in FIGS. 6-9 are bent toward the outer surface,i.e., in the embodiment of FIGS. 6-7 toward the surfaces 25, 35 thatcontain the bores 21 and holes 31, of the elongate members 20, 30 toform the lordotic curvature.

The entire elongate members 20, 30 may be straight, curved or portionsof the elongate members 20, 30 may be curved and/or straight. Forexample, the rod portions 22, 32 may be straight while the extensionportions 24, 34 may be curved (lordotic or kyphotic curvature orcombination) or vice versa, the extension portions 24, 34 may bestraight while the rod portions 22, 32 are curved. Other regions of theelongate members, or partial portions of the rod portions and/orextension portions may be a combination of curved and straight.

The adjustable rod assembly 10 preferably has one or more boneconnecting elements. The bone connecting elements may take on many formsand configurations, and may include, for example; hooks, including, forexample, spinal hooks, lamina hooks, pedicle hooks, transverse processhooks, spinous process hooks, spinal hooks, pelvic hooks, and S-hookmembers; clamp assemblies; screws, including, for example, pediclescrews, and pelvic screws. The clamp assembly may take many forms andconfigurations, such as, for example, a rib hook and a rib hook cap, a“C” clamp or other clamp configurations. The adjustable rod assembly inFIGS. 1-5 have two bone connecting elements 50, one attached to the rodportion 22 of the first elongate member 20 and one connected to the rodportion 32 of the second elongated member 30. The adjustable rodassembly of FIG. 15 has three bone connecting elements 50, one (notshown) connected to the rod portion 22, one connected to the proximalend of the rod portion 32 and one connected to a transverse bar 90.

The bone connecting elements 50 preferably are angularly adjustable withrespect to the elongate members 20, 30 by rotating the connectingelements 50 about and with respect to the elongate elements. The angularadjustability of the elongate elements is permitted and facilitated bythe preferred cylindrical shape of the rod portions 22, 32 of theelongate members interacting with openings, preferably U-shapedopenings, in the bone connecting elements 50. While the preferred shapeof the rod portions have been shown and described as cylindrical it willbe appreciated that other shapes and configurations that will providethe preferred angular adjustability of the bone connecting element 50with respect to the adjustable assembly 15 are contemplated. After thebone connecting elements 50 are oriented as desired with respect to therespective elongate member, the position of the connecting element 50may be fixed or secured with respect to the elongate element via alocking mechanism.

The bone connecting elements 50 in the embodiment of FIG. 1 aredifferent at each end of the adjustable rod assembly 10. The boneconnecting element 50 connected to the rod portion 22 of the firstelongate member 20 is in the form of a lamina hook 70, shown in FIG. 11.Lamina hook 70 may be formed as a single monolithic piece or multi-piecehook with a locking screw 56 for fixing the position of the hook 70along the length of the elongate member, such as, for example, elongatemember 20 in the embodiment of FIG. 1. The lamina hook 70 includes aclamping portion 71 and a hook portion 72. The hook portion 72 isconfigured, sized and oriented preferably to engage the lamina portionof the vertebrae but may be configured, sized and oriented to attach toother parts of the vertebrae, spine, rib, pelvis or other bones.

The clamping portion 71 preferably is formed as a C-clamp having athrough bore 73 and two leg portions 74, 74′. Each leg portion 74, 74′has a screw hole 55, 55′ extending there through to receive lockingscrew 56. The screw hole 55′ preferably has inner threads (not shown),preferably only on one leg, for example, leg 74′, that mate with thethreads on the locking screw 56 so that as the screw 56 is tightened,the gap 80 between the legs 74, 74′ decreases so that the size ofthrough bore 73 decreases to provide a clamping force on the rod portion22 to fix the position of the lamina hook 70 on the elongate member 20.The position of the lamina hook 70 along the length of the elongatemember, and preferably along the length of the rod portion 22, isadjustable by the surgeon. In addition, lamina hook 70 preferably can berotated about the longitudinal axis L of the elongate member 20 toadjust the angular orientation of the lamina hook 70 with respect to theelongate member 20 and the adjustable rod assembly 10. The screw hole55, 55′ preferably is orientated perpendicular to the through bore 73,but other angular relationships are contemplated.

The bone connecting element 50 connected to the second elongate element30 in the embodiment of the adjustable rod assembly 10 of FIG. 1 is inthe form of a clamping assembly 51 adapted for attachment to the rib ofa patient. While the clamping assembly 51 is shown and described asattaching to a rib, it can be appreciated that the clamping assembly canattach to other locations, parts and bones. The clamping assembly 51 maycomprise two or more pieces and as little as a single piece.

Clamping assembly 51 in FIGS. 1-5 includes a rib hook 60, a rib hook cap65 and locking element 40 for connecting the rib hook 60 to the rib hookcap 65. Rib hook 60 as shown in FIGS. 12-12B includes a hook portion 61and a connecting portion or body 62. Hook portion 61 is configured,sized and oriented preferably to fit at least partially around the ribof a patient. Connecting portion 62 includes an opening 63 to receivethe rod portion 22, 32 of the elongate members 20, 30. The rod portionis inserted in the opening 63 and preferably the angular orientation ofthe rib hook 60 can be adjusted with respect to the elongate members 20,30. That is, the shape of opening 63 permits the preferred cylindricallyshaped rod portion 22, 32 to rotate in the opening about longitudinalaxis L. The opening 63 in the embodiment of FIGS. 12-12B is preferablyU-shaped as shown, although other shapes are contemplated. The opening63 may be open at the back and bottom as shown in FIG. 12B, or theopening 63 in the back of body 62 may be substantially cylindricallyshaped. The rod portion 22, 32 may be locked and fixed with respect tothe clamp assembly 51 as explained below.

The connecting portion 62 of the rib hook 60 further includes an opening64 generally transverse to and preferably orthogonal to the opening 63.The opening 64 preferably intersects the opening 63 and a lockingelement 59 interacts and fits within the opening 64 to lock the elongatemembers 20, 30 with respect to the rib hook 60. A nut 17 preferably hasinternal threads that interact with threads formed on the lockingelement 59 to move the locking element 59 with respect to the body 62 tolock and fix the position of the rod portion of the elongate members.The locking element 59 includes an opening 16 sized to permit the rodportion of the elongate members to pass there through. To insert the rodportion of the elongate member in the opening 63 of the body 62, theopening 16 of the locking element overlaps and/or is aligned withopening 63 to permit the rod to pass through the opening 16. To lock theangular orientation and position of the rib hook 60 with respect to theelongate members the surgeon turns the nut 17 to move the lockingelement 59 so that the opening 16 of the locking element 59 shiftswithin the body 62 and clamps the rod portion in the body 62 to fix theposition of rib hook 60. The surgeon can adjust the angular orientationof the rib hook 60 on the elongate member by rotating the rib hook onthe elongate member and thereafter operating the nut 17 to fix theangular orientation of the rib hook 60 with respect to the elongatemember.

Alternatively, a set screw (not shown) may be fitted within the opening64 to lock and fix the position of the rod portion with respect to therib hook 60. the set screw would be turned to move the set screw so thatthe end of the set screw abuts against and clamps the rod portion in theopening 63. The set screw and opening 64 preferably would haveinteracting threads to couple the set screw to the rib hook 60 and tocontrol its movement in the opening 64.

The connecting portion or body 62 further includes the cap receivingportion 58 having an extension 54, a hole 57 through the extension 54,and a slot 53 below the extension 54 and above the hook portion 61. Alocking element 40, as will be described below, interacts with the capreceiving portion 58 and ledge 52 to connect the rib hook cap 65 to therib hook 60.

Rib hook cap 65 as shown in FIG. 13 has a hook portion 66 and aconnecting portion 67. The connecting portion 67 has an extension 68that is received in the slot 53 in the connecting portion 62. One ormore aligned but spaced apart holes 69 are provided in the connectingportion 67. The extension 68 is inserted into the slot 53 and one of theholes 69 is aligned with hole 57 and the locking element 40 is clippedover extension 54 and extension 68 so that the prong 41 extends downthrough the aligned holes 69 and 57. The side walls 47, 48 of thelocking clip 40 expand and deflect so that the projections 45 snap overledge 52 formed in the connecting portion 62. The locking element 40thereby preferably fixes the rib hook cap 65 to the rib hook 60. Thehook portion 61 of the rib hook 60 and the hook portion 66 of the ribhook cap preferably extend about and capture the patient's rib to act asa bone attachment anchor for the adjustable rod assembly 10. Because ofthe multiple holes 69, the size of the space created by the rib hook 60and rib hook cap 65 can be adjusted to fit different size ribs.Alternatively and additionally, different size rib hook caps 65 may beprovided, and/or different size rib hooks 60 may be provided in order toprovide different size bone connecting elements 50 for attachment to amultitude of different size ribs.

FIG. 2 shows an alternative second preferred embodiment of adjustablerod assembly 10. The bone connecting element 50 attached to one end ofthe assembly is the same as the clamping assembly 51 described inFIG. 1. The bone connecting element 50 attached to the other end of theadjustable rod assembly 10 comprises a S-hook connector 75. The S-hookconnector 75 has a hook portion 76 and a connecting portion 77. The hookportion 76 is shaped similar to an “S”-shape and preferably isconfigured and oriented as a pelvic hook and preferably is configuredand oriented to slip over the top of the pelvis in the area of the iliaccrest as shown in FIG. 3. The end 79 of the hook portion 76 is not inthe same plane as the middle portion or the end of the hook portion 76that is connected to the connecting portion 77. In this manner, end 79extends along the anterior side of the iliac crest while the arch orcurved section of the hook portion 76 extends up and over the iliaccrest. The remainder of the hook portion 76 extends down along theposterior side of the iliac crest and back up toward the rib cage. Theconnecting portion 77 is preferably a generally straight rod section 78that extends from the hook portion 76. Although rod section 78 is shownas generally straight it may also be curved and/or a combination ofstraight and curved sections. S-hook connector 75 may come in differentsizes and lengths. The hook portion 76 may come in different sizes tofit a variety of pelvis and the rod section 78 may come in a multitudeof different lengths to accommodate different size adjustable rodassemblies 10, for use in a variety of different patients.

The S-hook connector 75 is connected to the rod portion 32 of theelongate member 30 by parallel rod connector 85. Parallel rod connector85 has a body 86 with two parallel channels 87, 88 extending through thebody 86 and one or more openings 89 intersecting each of channels 87,88. In the embodiment of FIG. 2, two openings 89 intersect channel 87and two openings 89 intersect channel 88. The openings 89 are preferablythreaded and receive locking screws 84. The two channels 87, 88 may bethe same size and/or diameter or may be a different size. The rodsection 78 of the S-hook connector 75 may be inserted into and throughone of the channels, such as, for example, channel 88, while the rodportion 22, 32 of the elongate members 20, 30 may be inserted throughthe other channel, such as, for example, channel 87. The locking screws84 are tightened to fix the position and angular orientation of theS-hook connector 75 with respect to the parallel connector 85, and theposition and orientation of the parallel connector 85 with respect tothe elongate members.

While the embodiment of the adjustable rod assembly 10 in FIGS. 2 and 3uses parallel connector 85, an in-line connector (not shown) that hasone channel, for example, channel 87, may also be used. In-lineconnector has one or more, and preferably two or more openingsintersecting the channel for receipt of locking screws 84. The rodsection 78 of the S-hook connector 75 is inserted in the first end ofthe channel 87 of the in-line connector and fixed by tightening thelocking screw 84 while the rod portion of the elongate member isinserted in the second end of the channel 87 and fixed by tighteninglocking screw 84 to attach the S-hook connector 75 to the adjustable rodassembly 10.

A third preferred embodiment of adjustable rod assembly 10 is shown inFIGS. 4 and 5 and has two of the clamping assemblies 51 described inconnection with FIG. 1. One clamping assembly 51 is attached to one endof the adjusting assembly 15 while a second clamping assembly 51 isattached to the other end of the adjusting assembly 15. The elongatemembers 20, 30 making up the adjusting assembly 15 in the embodiment ofFIG. 1 are shown as being substantially straight, while the elongatemembers 20, 30 making up the adjusting assembly 15 in the embodiment ofFIGS. 2-5 are slightly curved, having a kyphotic curvature when attachedto the ribs, pelvis or vertebrae. In this regard, the ends of the curvedelongate members are bent inward toward the inner surface of theelongate member 20, 30. When the adjustable rod assembly is attached tothe posterior side of the back of the rib cage and/or posterior side ofvertebrae (lamina) or posterior side of the pelvis (as shown in FIG. 3)the radius of curvature is toward and defined by the inner surface ofthe elongate members forming a kyphotic curvature. The locking elementor coupler 40 which snaps over the outer surface of the adjustableassembly 15 faces the posterior side of the patient as shown in FIG. 3.

A fourth preferred embodiment of adjustable rod assembly 10 is shown inFIG. 15. The adjustable rod assembly in FIG. 15 includes adjustingassembly 15, a bone connecting element (not shown) connected to rodportion 22, a bone connecting element 50 attached to rod portion 32, anda second bone connecting element 50 operatively associated with the rodportion 32. The bone connecting element 50 attached directly to the endof the rod portion 32 is the clamping assembly 51 described inconnection with the adjustable rod assembly of FIG. 1. As illustrated inFIGS. 1-5, 12-12B and 15, the angular orientation of the clampingassembly 51 can be adjusted by rotating the clamping assembly 51 aboutthe longitudinal axis L of the rod portion 32 and turning the nut 17 tomove the locking element 59 to fix the position of the clamping assembly51 relative to the elongate member 30.

The bone connecting element 50 operatively associated with the rodportion 32 of the elongate member 30 is clamping assembly 51′ which issimilar to clamping assembly 51. The clamping assembly 51′ includes arib hook 95 and rib hook cap 65. The rib hook cap 65 in clampingassembly 51′ is the same as the rib hook cap 65 in clamping assembly 51.The transverse rib hook 95 as shown in FIGS. 17-17B is substantiallysimilar to rib hook 60 and includes the same hook portion 61 but aslightly modified connecting portion 62′. Instead of having a recess 63at the distal end of the body 62 which is aligned with the longitudinalaxis 12A-12A of the rib hook 60 as in clamping assembly 51, connectingportion 62′ of transverse rib hook 95 includes an open channel 63′ inthe connecting portion 62′ that is open at the bottom and sides of body62′ to form a U-shaped channel. Channel 63′ is not open at the distalend or back of body 62′ as with opening 63 in rib hook 60. Leg portion96 of the locking element 59 closes channel 63′ and is moveable in orderto adjust the size of the opening 97 provided by the open channel 63′and the leg portion 96. Operation of nut 17 moves locking element 59which moves the leg portion 96 of the locking element 59 to adjust thesize of the opening 97. The body 62′ and the leg portion 96 form a clampto fix and lock the transverse rib hook 95 to transverse bar 90. Theopening 97 formed by the locking element 59 and body 62′ in rib hook 95is generally transverse to and preferably perpendicular to the opening16 formed by the locking element 59 and body 62 in rib hook 60.Alternatively, instead of nut 17 and locking element 59, a set screw asdescribed above in connection with rib hook 60 of FIGS. 12-12B may beused to abut against and fix the position of the transverse rib hook 95with respect to transverse bar 90.

The clamping assembly 51′ is laterally offset and preferably generallyparallel to the clamping assembly 51. Transverse bar 90 is provided tolaterally offset the clamping assembly 51′. The transverse bar 90includes a clamping portion 91 and a shaft portion 92. The shaft portion92 is preferably round and cylindrically shaped. The shaft portion 92 isreceivable within the opening 97 formed in the transverse rib hook 95 bythe channel 63′ and the leg portion 96. The shaft portion 92 is slidablewithin the opening 97 of the transverse rib hook 95 to adjust the amountof lateral offset, i.e., the distance X that the bone connectingclamping assembly 51′ is spaced from the clamping assembly 51. Thetransverse rib hook 95 is also angularly adjustable with respect to thetransverse hook 90 by rotating the transverse rib hook 95 about theshaft portion 92. The position of the transverse rib hook 95 along thelength of the transverse hook 90 and the angular orientation of thetransverse rib hook 95 with respect to the transverse hook 90 may beadjusted and thereafter fixed by turning the nut 17 to move the lockingelement 59 in the transverse rib hook 95 to clamp the shaft portion 92between the leg portion 96 and the connecting portion 62′. Serrations 93may be provided in the shaft portion 92 to interact with serrations 98formed on leg portion 96. The serrations 93, 98 may assist in theclamping action of the shaft portion 92 in the transverse rib hook 95and/or provide detents to provide predetermined angular orientations.For example, the serrations 93, 98 can be provided at predeterminedangular intervals, such as, for example, 5° intervals, so that thesurgeon can vary the angular position of the transverse rib hook 95 inknown intervals.

The clamping portion 91 of the transverse bar 90 may include a hookportion 94 that includes an opening 82 sized and configured to receivethe rod portion 22, 32 of the elongate members 20, 30. In FIG. 15, theopening 82 of the transverse bar 90 is fitted over and clamped to rodportion 32 of elongate member 30 but it can be appreciated that one ormore additional transverse bars 90 and clamping assemblies 51′ can beattached to rod portions 22 or 32. A set screw 99 is tightened to fixthe position of the transverse hook 90 on the rod portion. Thetransverse hook 90 can angularly adjust with respect to the rod portionand can slide along the length of the rod portion to adjust the positionand orientation of clamp assembly 51′ with respect to the adjustingassembly 15 and the elongate members 20, 30. The transverse bar 90 issubstantially similar to the transverse bar described and illustrated inU.S. Pat. No. 7,118,571, the contents of which are incorporated byreference in their entirety herein.

While the adjustable rod assembly 10 in FIG. 15 is shown as having twobone connecting elements 50 attached to elongate member 30 it can beappreciated that transverse bar 90 and bone connecting assembly 51′ canbe utilized without bone connecting clamping assembly 51. Alternatively,additional transverse bars 90 and bone clamping assemblies 51′ can beutilized with the embodiment of FIG. 15, or the embodiments of FIGS.1-6, either attached to rod portion 32 or attached at the other end ofthe adjustable rod assembly 10 to rod portion 22. The transverse bar 90and clamp assembly 51′ permit the adjustable rod assembly to attach atseparate locations along the same rib, and/or permit the same end of theelongate member, e.g., rod portion 32, to attach to multiple ribs.

Any one of bone connecting elements 50 may be attached to elongatemembers 20, 30 including, but not limited to, lamina hook 70, S-hooks75, clamping assemblies 51 and 51′. Other bone connecting elements notshown may also be utilized in the adjustable rod assembly, such as, forexample, pedicle screws or pedicle hooks. The pedicle screws preferablywould have a screw portion for engaging the bone and a body with arod-receiving channel and a locking mechanism to lock the elongatemember 20, 30 in position in the rod-receiving channel. The pediclehooks preferably would have a hook portion for engaging and attaching tobone and a body with a rod-receiving channel and a locking mechanism tolock the elongate member 20, 30 in position in the rod-receivingchannel. Exemplary embodiments of pedicle screws include those describedin International Patent Application No. PCT/US2008/070670, filed on Jul.21, 2008, entitled “Polyaxial Bone Fixation Element”, InternationalPatent Application No. PCT/US2006/015692, filed on Apr. 25, 2006,entitled “Bone Anchor with Locking Cap and Method of Spinal Fixation”,and International Patent Application No. PCT/CH1997/00236, filed on Jun.16, 1997, entitled “Device for Connecting a Longitudinal Support with aPedicle Screw”, the contents of which are hereby incorporated byreference in their entirety. It should be understood however that thepresent invention is not limited in use to any particular type ofpedicle screw.

The bone connecting elements 50 can be formed of a number ofbiocompatible materials, such as, for example, titanium, stainlesssteel, titanium alloy, cobalt-chrome, composites, ceramics, PEEK, orother polymers. These materials are not limiting and the bone-connectingelements may be constructed of nearly any biocompatible material that isable to take on the desired shape and withstand the normal operatingconditions (e.g., environmental and physical property requirements) ofthe bone connecting elements 50.

In operation, the adjustable rod 10 can be used alone or in conjunctionwith a rib cage corrective device or conventional screw/hook systemknown in the art. To mount the adjustable rod assembly 10 to a patient'sspine, rib cage and/or pelvis in the preferred embodiment, two boneconnecting elements 50 are implanted. The extension adjusting assembly15 can be assembled preoperatively by coupling the first elongate member20 to the second elongate member 30 by sliding the male expansionportion 24 into the female expansion portion 34 and aligning at leastone of the plurality of through holes 31 with at least one of theplurality of blind boreholes 21 and placing the locking element 40 overthe female expansion portion 34 and through a pair of aligned throughholes 31 and blind holes 21. The length of the adjustable rod assembly10 is adjustable via the choice of aligned holes 31/21. The first rodportion 22 and the second rod portion 32 are then coupled to therod-receiving portions of the previously implanted bone connectingelements 50. The angular orientation of the bone connecting elements 50relative to the rod portions 22, 32 may be adjusted pre-operatively orduring the procedure. Post operative adjustments to the expandable rodassembly 10 to accommodate growth of a developing spine or progressivecorrection of a deformed spine can be performed by making a smallopening near the locking element 40, uncoupling the locking element 40from the extension adjusting assembly 15, distracting the first elongatemember 20 from the second elongate member 30, and recoupling the lockingelement 40 to an alternate pair of aligned holes 31/21.

In an alternate method of mounting the preferred adjustable rod assembly10 to a patient's spine, ribcage and/or pelvis, the adjustable rodassembly 10 can be implanted in a minimally invasive manner andassembled in situ. In this preferred method, two bone connectingelements 50 are implanted via small openings, preferably formed by smallincisions. The first and second elongate members 20, 30 are theninserted through one or more small openings, which in one embodiment canbe the same small incisions used to implant the pair of bone connectingelements. The first and second elongate members 20, 30 then may becoupled to the bone connecting elements. The first and second elongatemembers 20 and 30 are then coupled using the locking element 40 via athird small opening, preferably a third small incision. In addition,this method may be performed through a mini-opening formed in thepatient.

The first and second rod portions 22, 32, as well as the male and femaleexpansion sections 24, 34, can be provided in a range of differentcurvatures to match the desired lordotic/kyphotic attributes for theadjustable rod assembly 10. The elongate members 20, 30 also can bestraight. Combinations of curved and straight portions are alsocontemplated. For example, the rod portions 22, 32 can be straight whilethe extension portions are curved, or vice versa, the extension portionscan be straight and the rod portions curved. Alternatively the entireelongate members may be curved, or the entire elongate members may bestraight. Preferably, if the extension portions 24, 34 are curved, theyboth have substantially the same curvature, preferably in the regionswhere they overlap or telescope one elongate member with respect to theother elongate member.

The adjusting assemblies 15 may be supplied as a kit with multiplepieces in different sizes and curvatures. For example, multiple elongatemembers 20, and multiple elongate members 30 can be provided each with adifferent radii of curvature, such as for example, a set with 220 mmradius and a set with 500 mm radius. In addition each elongate memberwith a different radius of curvature may be provided in multipledifferent lengths, and multiple different thickness so that differentsize patients can be treated. The first and second rod portions 22, 32,as well as the male and female expansion sections 24, 34, can also beprovided in a range of different lengths. The first and second rodportions 22, 32, as well as the male and female expansion sections 24,34, can also be provided in a range of different rigidities, or mayinclude damping elements to provide dynamic stabilization to desiredspinal levels. The first and second rod portions 22, 32 also may beformed with differing diameters, e.g., 4.5 mm and 6.0 mm, such that alow profile bone connecting element 50 can couple to the first rodportion 22 and a more robust bone connecting element can couple to thesecond rod portion 32, or vice versa.

While the foregoing description and drawings represent the preferredembodiments of the present invention, it will be understood that variousadditions, modifications, combinations and/or substitutions may be madetherein without departing from the spirit and scope of the presentinvention as defined in the accompanying claims. In particular, it willbe clear to those skilled in the art that the present invention is notlimited to the particular embodiments shown but may be embodied in otherspecific forms, structures, arrangements, proportions, and with otherelements, materials, and components, without departing from the spiritor essential characteristics thereof. One skilled in the art willappreciate that the invention may be used with many modifications ofstructures, arrangement, proportions, materials, and components used inthe practice of the invention, which are particularly adapted tospecific environments and operative requirements without departing fromthe principles of the present invention. In addition, features describedherein may be used singularly or in combination with other features. Thepresently disclosed embodiments are therefore to be considered in allrespects as illustrative and not restrictive, the scope of the inventionbeing indicated by the appended claims, and not limited to the foregoingdescription.

We claim:
 1. An adjustable rod assembly for correcting or straighteninga human spine, the adjustable rod assembly comprising: at least one boneconnecting element for attaching to the rib cage, pelvis or spine of apatient; a first elongate member including a first rod portionconfigured for coupling to one of the bone connecting elements and afirst expansion portion, the first expansion portion further including aplurality of bore holes in an outer surface; a second elongate memberincluding a second rod portion configured for coupling to one of thebone connecting elements and a second expansion portion slidablymoveable with respect to the first expansion portion, the secondexpansion portion further including a plurality of through holes in anouter surface; and a locking element including a pin configured to beinsertable into at least one of each of the bore holes and the throughholes to thereby couple the first and second elongate members togetherand fix the length of the adjustable rod assembly, wherein the boneconnecting element is rotationally adjustable about at least one of thefirst rod portion and the second rod portion.
 2. The adjustable rodassembly of claim 1 wherein the first and second elongate members arecurved.
 3. The adjustable rod assembly of claim 1 wherein the firstexpansion and second expansion portions are each curved and each has thesame radii of curvature.
 4. The adjustable rod assembly of claim 3wherein the radius of curvature of the first and second expansionportions is between about 200 mm to about 520 mm.
 5. The adjustable rodassembly of claim 1 wherein at least one of the bone connecting elementsis a lamina hook.
 6. The adjustable rod assembly of claim 1 wherein atleast one of the bone connecting elements includes a clamp assembly. 7.The adjustable rod assembly of claim 6 wherein the clamp assemblyincludes a rib hook and a rib hook cap for attaching to the rib cage. 8.The adjustable rod assembly of claim 1 wherein the first rod portion hasat least a portion that is substantially cylindrically shaped and atleast one bone connecting element has an opening to receive thesubstantially cylindrically shaped rod portion to permit angularadjustment of the bone connecting element relative to the first rodportion.
 9. The adjustable rod assembly of claim 1 further comprising aplurality of first elongate members of different sizes and shapes and aplurality of second elongate members of different sizes and shapes. 10.The adjustable rod assembly of claim 9 further comprising a plurality ofbone connecting elements, including at least one clamp assembly forattachment to a patient's rib, at least one hook for attachment to thepatient's spine and at least one hook for attachment to the patient'spelvis.
 11. The adjustable rod assembly of claim 9 further comprising atleast one transverse bar.
 12. The adjustable rod assembly of claim 1wherein the second expansion portion is formed as a sleeve having achannel for receiving at least a portion of the first expansion portion.13. The adjustable rod assembly of claim 1 wherein the first expansionportion is curved and the first rod portion is straight.
 14. Theadjustable rod assembly of claim 1 wherein the first and second elongatemembers are relatively straight.
 15. The adjustable rod assembly ofclaim 1 where in at least a portion of the first elongate member has alordotic curvature.
 16. An adjustable rod assembly for correcting orstraightening a human spine, the adjustable rod assembly comprising: atleast one bone connecting element for attaching to the rib cage, pelvisor spine of a patient; a first elongate member including a first rodportion configured for coupling to one of the bone connecting elementsand a first expansion portion, the first expansion portion furtherincluding a plurality of bore holes in an outer surface; a secondelongate member including a second rod portion configured for couplingto one of the bone connecting elements and a second expansion portionslidably moveable with respect to the first expansion portion, thesecond expansion portion further including a plurality of through holesin an outer surface; and a locking element including a pin configured tobe insertable into at least one of each of the bore holes and thethrough holes to thereby couple the first and second elongate memberstogether and fix the length of the adjustable rod assembly, wherein thebone connecting element is rotationally adjustable about at least one ofthe first rod portion and the second rod portion, and at least a portionof the first elongate member is straight or has a lordotic curvature.17. A method of implanting an adjustable rod assembly for correcting orstraightening a human spine, comprising the steps of: inserting a firstbone connecting element through a first opening to a first location in apatient; coupling the first bone connecting element to bone at the firstlocation; inserting a second bone connecting element through a secondopening to a second location in a patient; coupling the second boneconnecting element to bone at the second location; inserting a firstelongate member through the first opening; coupling the first elongatemember to the first bone connecting element; inserting a second elongatemember through the second opening; coupling the second elongate memberto the second bone connecting element; and coupling the elongate memberstogether.
 18. The method of claim 16 further comprising the steps ofcreating a third opening at a third location and inserting a couplerthrough the third incision to couple the elongate members together. 19.The method of claim 16 wherein the first elongate member has a first rodportion and the method further comprises the steps of coupling the firstbone connecting element to the first rod portion; and angularlyadjusting the first bone connecting element relative to the first rodportion.
 20. The method of claim 19 further comprising the step offixing the angular orientation of the first bone connecting element withrespect to the first rod portion.